1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Defect depth reduction (%)
研究概览
简要总结
The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.
详细描述
Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.
Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
- •Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy
排除标准
- •Patients with any other known systemic disease
- •Patients on systemic statin therapy
- •Known or suspected allergy to statin supplementation
- •Patients with aggressive periodontitis
- •Tobacco use in any form, smokers, alcoholics
- •Immunocompromised patients
- •Pregnant or lactating females
研究组 & 干预措施
Rosuvastatin group
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
干预措施: SRP plus Rosuvastatin gel (Drug)
Placebo group
Oral prophylaxis followed by placebo gel placement in intrabony defects
干预措施: SRP plus placebo gel (Drug)
结局指标
主要结局
Defect depth reduction (%)
时间窗: Change from baseline to 9 months
Assessed in percentage
次要结局
- plaque index(Change from baseline to 9 months)
- probing depth (mm)(Change from baseline to 9 months)
- clinical attachment level (mm)(Change from baseline to 9 months)
- modified sulcus bleeding index(Change from baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and Head, Dept of Periodontology
Government Dental College and Research Institute, Bangalore